NCT00492869已完成1 期
A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 41
- 主要终点
- Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms
研究概览
简要总结
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of any race 18 years or older
- •Adult recipients of kidney transplant from a deceased or living donor
- •Recipients of a functioning kidney within 24 hours post transplant
- •Need for medication prohibited by the protocol
- •Patients or donors infected with Hepatitis B,C or HIV
- •Patients with a history of cancer within last 5 years
- •Patients with history of significant cardiac disorder
- •Patients of high-risk immunological status
- •Other protocol-defined inclusion/
排除标准
- 未提供
结局指标
主要结局
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms
次要结局
- Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
研究者
研究点 (41)
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